Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence

Urinary Stress Incontinence Clinical Trial

Official title:

Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288648
• Other study ID #: HU 26/2020
• Status: Completed
• Start date: May 17, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment.

Description:

The main goal of this study is to compare the ability of the pelvic floor muscles to contract in different positions among women suffering from SUI to healthy women. Secondary objectives: is to compare subjective reports of the difficulty to contract the pelvic floor muscles between the two groups, and to examine the connection between the severity of urinary leakage and the ability to contract pelvic floor muscles.

The study will include 50 female participants in the ages of 18-45. Research group will include 25 participants suffering from SUI in accordance with the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and 25 healthy participants (grade 0 on the ICIQ-SF questionnaire).

The examination will be performed with an abdominal ultrasound device in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. The extent and direction of bladder base movement would indicate the quality of pelvic floor performance. Next, the length of contraction time will be measured. The participant would hold the maximal contraction as long as possible in order to examine muscular endurance. Rest will be given between tests. After finishing the tests in all four postures, the participants will be questioned about the degree of difficulty contracting the pelvic floor.

Significance of the study: The importance of the research is about granting the clinicians and researchers additional tools in order to help establishing a protocol for pelvic floor muscle activity examination and treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria (general):

• willing to participate in the study

• being able to squat for over 10 seconds.

• inclusion for study group - participants suffering from SUI that received a grade>0 in sections 3+4 (how frequent does urinary leakage appear, the amount of urine leakage and does the participant use pads for leakage absorption) and a grade>0 in section 5 (how much does SUI interrupt the participant's daily life) in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).

• Inclusion for control group - healthy participants (grade 0 in the ICIQ- SF questionnaire).

Exclusion Criteria:

• Other types of urinary leakage

• receiving pelvic floor treatments in the past or present

• active urinary or vaginal infections

• neurological diseases

• urologic, gynecologic or abdominal surgery

• pelvic organ prolapse

• pregnancy

• chronic cough

• constipation

• unbalanced diabetes and the use of medication that affects urination

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Diagnostic Test:
• ultrasound examination
ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.

Locations

Country	Name	City	State
Israel	Haifa University, Department of PHysical Therapy	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Sapsford RR, Richardson CA, Stanton WR. Sitting posture affects pelvic floor muscle activity in parous women: an observational study. Aust J Physiother. 2006;52(3):219-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	direction of urinary bladder displacement during contraction	upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound	baseline
Secondary	urinary bladder displacement in millimeters	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool	baseline
Secondary	pelvic floor muscles endurance of contraction in seconds	time of muscle contraction will be measured during the last contraction	baseline
Secondary	questioned about the degree of difficulty contracting the pelvic floor.	Each participant will grade on a scale of 1-10 (10 most difficult) the subjective difficulty of contraction in each position	baseline